Overview
This role involves providing legal support to ensure compliance with laws, regulations, and best practices related to the wholesale distribution and export of prescription drugs, medical devices, nutritional products, and food supplements. The Regulatory Counsel will also advise and represent the organization in matters involving government oversight and enforcement actions.
Responsibilities
- Support and report to senior legal leadership on legal and regulatory matters focused on wholesale distribution and export of pharmaceuticals and related products.
- Represent the organization during inspections and investigations by government oversight and enforcement agencies.
- Advise on the application and implementation of federal and state laws governing domestic and international pharmaceutical distribution, including the Food Drug & Cosmetic Act, Drug Supply Chain Security Act, BIS and OFAC regulations, patient privacy laws, relevant Executive Orders, and industry trends.
- Provide guidance on developing, implementing, and updating policies and standard operating procedures to comply with FDA regulations, supply chain integrity requirements, fraud and abuse statutes, anti-corruption laws, and pharmaceutical industry best practices.
- Advise relevant departments during audits by corporate donors of pharmaceuticals.
- Deliver timely and actionable regulatory and statutory advice to management and department heads.
- Collaborate with all departments to develop strategies addressing unique legal, regulatory, and organizational challenges.
- Proactively identify and mitigate liability risks.
- Support review and quality control of legal work performed by retained counsel in the United States, Germany, and Mexico.
- Perform other duties as assigned by senior legal leadership.
Required Qualifications
- J.D. or L.L.M. from an accredited law school.
- At least 5 years of relevant legal experience in a law firm, government, and/or in-house role.
- Admission to the California Bar in good standing, eligibility to practice as California Registered in-house counsel under California Rules of Court 9.46, or authorization to practice from home jurisdiction.
- Experience interfacing with government oversight and enforcement agencies such as FDA, DEA, HHS OIG, FBI, BIS, OFAC, state Boards of Pharmacy, or California Attorney General’s Office.
- Demonstrable knowledge of laws and best practices governing domestic and/or international pharmaceutical distribution, including FDA regulations under the Food, Drug & Cosmetic Act, supply chain integrity (DSCSA/FMD), and Good Distribution Practices.
- Strong written, verbal, and interpersonal communication skills with the ability to influence diverse stakeholders and operate with minimal oversight.
- Strong analytical, critical thinking, and problem-solving abilities.
- Ability to adapt to changing priorities and manage multiple assignments with deadlines.
- Successful completion of background check and toxicology screening.
Preferred Qualifications
- Over 3 years of legal experience in the pharmaceutical industry and/or at a regulatory body relevant to this work (e.g., FDA or state Board of Pharmacy).
- Experience advising on US and/or EU export controls related to pharmaceuticals or other medical products.
Compensation & Benefits
- Generous medical, dental, and vision insurance plans.
- Flexible spending account.
- 401(k) retirement plan.
- Accrued paid time off.
- Life insurance and disability coverage.
- Additional life and wellness benefits.
Location
Not specified.